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Do you need FDA approval to sell skincare?
No — with one real exception. But since MoCRA there are obligations that do apply to a first-time brand, and a few that fall on your manufacturer rather than you.
The short answer is no. Cosmetics sold in the United States do not go through a pre-market approval process the way drugs and medical devices do. Nobody at the FDA reviews your serum before you sell it, and there is no certificate to obtain.
There is one genuine exception, and then a set of obligations that are not approval but are not optional either. Since the Modernization of Cosmetics Regulation Act — MoCRA, enacted at the end of 2022 and the largest change to US cosmetics law in eighty years — that set is meaningfully longer than it used to be, and most of the advice still circulating online predates it.
The one real approval: colour additives
Colour additives are the exception. They must be approved by the FDA for the specific use, and some require batch certification. If your product is coloured — a tinted balm, a blush, a shampoo with dye in it — the colourant has to be on the permitted list for that application. Eye-area use has its own, narrower list. This is a genuine pre-approval regime, and it is the only one in cosmetics.
In practice your manufacturer handles it, because they are choosing the colourant. It is still worth asking the question explicitly, because “is every colourant in this formula approved for this application?” is a question a good supplier answers instantly and a weak one goes quiet on.
What MoCRA asks of you
| Obligation | Whose job | Reference |
|---|---|---|
| Facility registration | Your manufacturer | MoCRA §607 |
| Product listing | You, as the responsible person | MoCRA §607 |
| Safety substantiation on file | You, using their testing | MoCRA §608 |
| Adverse event contact on the label, and records kept | You | MoCRA §605 |
| Ingredients in INCI order on the pack | You | 21 CFR 701.3 |
| Net quantity, responsible person, batch code | You | 21 CFR 701 |
The split in that column is the thing to take away. Registration is the facility's obligation, not yours — but you need to know they have done it, because your product's listing refers to the facility that made it. Safety substantiation is yours, and you satisfy it largely with documents your manufacturer produces: the testing, the stability data, the certificate of analysis. You are the one who has to hold them.
“Responsible person” is a defined role and it is almost certainly you. It means your name and a contact address go on the pack, and that adverse event reports come to you and get recorded. It is not onerous — an email address that a human reads and a file that it goes into — but it is a legal position, not a formality.
The small-business exemption, carefully
MoCRA includes an exemption from the registration and listing requirements for smaller businesses, keyed to average gross annual sales over the preceding three years. It does not exempt certain product categories — among them products that come into contact with the mucous membrane of the eye in normal use, products that are injected, products intended for internal use, and products intended to alter appearance for more than 24 hours without being removed by the consumer.
It also does not exempt anything else on the list above. Labelling, safety substantiation and adverse event obligations apply regardless of size. If you are relying on the exemption, check the current threshold and the excluded categories against the statute rather than a blog post — including this one.
The line you actually have to watch: cosmetic or drug
This is where first-time founders get into trouble, and it has nothing to do with paperwork. A product's regulatory category in the United States is determined largely by what you claim it does. “Moisturises” is cosmetic. “Treats eczema” is a drug claim. “Reduces the appearance of fine lines” is cosmetic; “stimulates collagen production” is asking for a fight. Sunscreen is an over-the-counter drug in the US, with a monograph and testing requirements, whatever the rest of the product does.
The same jar of cream is a cosmetic or an unapproved new drug depending entirely on the sentence on the front. This is why claims belong in your brief on day one rather than in a marketing sprint at the end — the brief, field by field.
Insurance is not the FDA, and you still need it
Product liability insurance is not a regulatory requirement, and it is effectively a commercial one: Amazon, most retailers and many stockists will ask for a certificate before your first order. Founders discover this at the point of their first wholesale conversation, which is the worst time. Sort it before the first sale.
What to ask your manufacturer
- Are you registered with the FDA under MoCRA, and will you confirm the registration number in writing?
- Is every colourant in this formula approved for this application, including eye-area use if relevant?
- What safety substantiation will you provide, and in what form?
- Will you supply a certificate of analysis for each batch, and a stability study in my final packaging?
- Will you give me an INCI list I can put on the pack?
A supplier who answers all five without hesitating has done this before. One who answers none of them may still be a real factory — but you have just learned that the compliance work is going to be yours to drive. Seven checks before you send a brief covers how to tell.
Batchkind builds the compliance list for your category and channel, marks what is your job and what is your supplier's, and shows the rule behind each line.
Turn your idea into a brief